Chronic Kidney Diseases, Hemodialysis Complication, Hyperphosphatemia
Conditions
Keywords
chronic kidney disease, hyperphosphatemia in chronic adult hemodialysis patients, bile acid sequestrants: cholestyramine, serum calcium level, serum phosphate level
Brief summary
After the end of trial, we will examine if cholestyramine has a significant efficacy on reducing serum phosphate level in adult hemodialysis patients. Time of the trial will be two months (8 weeks trial period) Baseline characteristics: The following data will be collected from all patients at baseline 1. Age, sex, weight, duration of ESRD and hemodialysis comorbidities. 2. Dialysis duration, serum phosphate level, serum calcium level, iPTH, BUN, Cr (mg/d L), Albumin (mg/d L), Hb (g m%), renal function test, liver function test, blood glucose level, TG, total cholesterol level, LDL-C, HDL.C. After the end of trial, we will examine if cholestyramine has a significant efficacy on reducing serum phosphate level in adult hemodialysis patients.
Detailed description
Chronic kidney disease-mineral and bone disorder (CKD-MBD) is characterized by progressive loss of renal function as well as dysregulation of mineral and bone metabolism, leading frequently to hyperphosphatemia. Multiple studies have consistently shown that hyperphosphatemia is associated with cardiovascular events and increased morbidity and mortality in end-stage renal disease (ESRD) patients. Importantly, use of phosphate binding agents and reduction of serum phosphate concentration are associated with a lower risk of mortality. The most widely used phosphate binders are calcium-based, although they are frequently associated with hypercalcemia and vascular calcification. Colestilan is a non-metallic phosphate binder that acts as an anion-exchange resin. Colestilan itself is not absorbed after oral administration, and it is able to bind dietary phosphate within the gastrointestinal tract and thus prevent absorption of the mineral. A total of 80 patients will be recruited and divided into 2 groups: - Group 1: 40 patients will take a dose of cholestyramine 4-gram sachet three times daily with standard therapy (Calcimate). Group 2: 40 patients will take only the standard therapy (Calcimate). Time of the trial will be two months (8 weeks trial period) Baseline characteristics: The following data will be collected from all patients at baseline 1. Age, sex, weight, duration of ESRD and hemodialysis comorbidities. 2. Dialysis duration, serum phosphate level, serum calcium level, iPTH, BUN, Cr (mg/d L), Albumin (mg/d L), Hb (g m%), renal function test, liver function test, blood glucose level, TG, total cholesterol level, LDL-C, HDL.C. After the end of trial, we will examine if cholestyramine has a significant efficacy on reducing serum phosphate level in adult hemodialysis patients. Parameters will be collected from all patients after 8-week trial period: Serum phosphate, serum calcium, iPTH, LDL, TG and total cholesterol level
Interventions
DRUGCholestyramine Resin 4000 MG [Questran]
cholestyramine 4 gram sachets (questran) will be administered orally three times daily for 8 weeks period trial
control group will administer standard therapy calcimate 500 mg three times daily within meals
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A total of 80 patients will be recruited and divided into 2 groups: - Group 1: (cholestyramine 12 gram), 40 patients will take a dose of cholestyramine 4-gram sachet three times daily with standard therapy(Calcimate). Group 2: Control group, 40 patients will take only the standard therapy (Calcimate). Time of the trial will be two months (8 weeks trial period)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* • Patients aged ≥18 years with CKD stage (4&5) * Serum phosphate level ≥ 5.5 mg/dL * Serum LDL-C level ≥1.82 mmol/L (70 mg/dL) * Hemodialysis frequency 3 times per week or more. * Hemodialysis in the last 3 months or longer.
Exclusion criteria
* Patients are excluded if they have a history of dysphagia, or swallowing disorder. 2-patients require warfarin or digoxin treatment. 3- Patients have a history of alcohol or substance abuse 4- Patients receiving calcimimetics. 5- Pregnant patients. 6- Patients have Triglyceride level above 300 (mg/dl)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum phosphate level | 8 weeks trial period | measuring serum phosphate level at baseline and after 8 weeks trial period to evaluate serum phosphate reduction by cholestyramine |
| serum calcium level | 8 weeks trial period | measuring serum calcium level at baseline and after 8 weeks trial period to evaluate serum calcium reduction by cholestyramine |
| iPTH | 8 weeks trial period | measuring iPTH level at baseline and after 8 weeks trial period to evaluate iPTH reduction by cholestyramine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid Profile ( triglyceride level , LDL ,HDL ,Total cholesterol ) | 8 weeks trial period | measuring LDL , total cholesterol reduction after using cholestyramine for 8 weeks trial period |
Countries
Egypt
Outcome results
None listed